MAUDE Adverse Event Report: PHILIPS NORTH AMERICA CORPORATION INTELLIVUE TRX+ TRANSMITTER; TELEMETRY TRANSMITTER

Model Number M4841A

Device Problems Break (1069); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

Approximately 35 telemetry transmitters have heated enough for nursing to have concerns for patient burns.Upon investigation by biomed, some units found to have heat damage to the battery and casing.These events started approximately in (b)(6) 2015 at which time the manufacturer was notified.We are aware of one employee that has been burned when removing the batteries.Reason for use: cardiac condition.

• Brand Name: INTELLIVUE TRX+ TRANSMITTER
• Type of Device: TELEMETRY TRANSMITTER
• Manufacturer (Section D): PHILIPS NORTH AMERICA CORPORATION; 3000 minuteman road m/s 109; andover MA 01810
• MDR Report Key: 5440640
• MDR Text Key: 38412433
• Report Number: MW5060212
• Device Sequence Number: 1
• Product Code: DRT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4841A
• Device Catalogue Number: 862439
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention